ISO 9000 Checklist-e

Industry Canada - Page 1

ISO 9000 SELF ASSESSMENT CHECKLIST The following 20 clauses of the ISO 9000 series of standards are covered in this self-assessment checklist:

ISO 9000 Clause ISO 9001

ISO 9002

ISO 9003

4.1 Management Responsibility # # #

4.2 Quality System # # #

4.3 Contract Review # # *

4.4 Design Control # 4.5 Document and Data Control # # *

4.6 Purchasing # # 4.7 Control of Customer-Supplied Product # # *

4.8 Product Identification and Traceability # # #

4.9 Process Control # # 4.10 Inspection and Testing # # #

4.11 Control of Inspection, Measuring and Test Equipment # # *

4.12 Inspection and Test Status # # *

4.13 Control of Nonconforming Product # # #

4.14 Corrective and Preventive Action # # #

4.15 Handling, Storage, Packaging, Preservation and Delivery # # *

4.16 Control of Quality Records # # #

4.17 Internal Quality Audits # # #

4.18 Training # # #

4.19 Servicing # # 4.20 Statistical Techniques # # #

# Comprehensive requirement * Less comprehensive requirement than 9001 and 9002

This Checklist has been designed to allow you to perform a self-assessment of your company’s current quality management practices by indicating True (T), Not Sure (?), or False (F) in the corresponding boxes. Any statements that you mark with either ? or F will require some form of action. Use the comments column to make notes to yourself regarding follow-up action or names. You may want different individuals to complete separate checklists in order to compare perceptions within your organization. (T) True: if you are in agreement with the statement (?) Not Sure: if you are unsure and may require input from someone else (F) False : if you know the statement is false The following individuals have participated in the completion of this checklist (number ____ of ____ total) :


Completed By: ___________________________ initial: ________ date: ________________ ___________________________ initial: ________ date: ________________ ___________________________ initial: ________ date: ________________


4.1 Management Responsibility 4.1.1 Quality Policy In order to steer efforts towards a common objective of quality, the company must institute a coherent quality policy and communicate it to all employees. This policy guides the company in day to day operations and serves to identify the company's fundamental principles and its commitment to quality. From this policy flow precise and measurable objectives. The company has a clearly defined and sufficiently explicit quality policy which guides day to day decision making. The policy takes into account the needs of the company and the needs and expectations of your customers.

There are specific, documented quality objectives, which provide for the achievement and measurement of results and which promote improvement.

The quality policy has been thoroughly communicated and is incorporated and rooted in all facets of the company

The company's quality objectives have been communicated and transmitted, as measurable goals, throughout the company.

Our quality policy is closely adhered to throughout the company. 4.1.2 Organization 4.1.2.1 Responsibility and Authority To be assured of the quality of a product or service, a company should assign certain tasks and responsibilities. The responsibilities of those persons who have a direct impact on quality should be documented. When quality problems arise in the company, people know to whom these problems should be addressed for resolution.

When it comes to accepting, refusing or rejecting a product, there is always a person who has the authority to make such a decision.

Employees always address the appropriate person in authority on matters of acceptance, refusal or rejection of a product.

These same people have complete authority and autonomy to execute their tasks. The company has clearly documented the responsibilities and authority of those persons charged with inspection, acceptance, rejection or disposition of a product, as well as with the inspection of the resolution process.

The company clearly charts and demonstrates a schematic of the association between those employees who have a direct impact on quality.

This schematic of relationships corresponds precisely to your actual situation. Those responsible for analyzing quality results and recommending improvements or changes do so efficiently and consistently.

4.1.2.2 Resources An important aspect of a company's quality process rests with its ability to identify, measure and plan quality throughout each phase of the development of its products and services. To do this, the company must have sufficient personnel. These employees must be qualified and be provided with the necessary tools to ensure the quality of their work and the products they produce. Employees responsible for inspection have sufficient time to complete their task, even when business is unusually hectic.

Employees responsible for inspection have received sufficient training and are highly competent in their jobs. When we receive new contracts, we re-evaluate the need for more staff or equipment to ensure the product or service will continue to meet standards.

For each new product or service our company introduces, we take the time to clearly identify elements that will require verification (inspection plan) and that which we will need to acquire to ensure that the product or service meets all the customer's requirements and expectations.

Explicit, documented procedures ensure that requisite staffing and equipment are identified in order to meet the customer's needs.

ISO 9000 Self Assessment Checklist T ? F Comments


These procedures are adhered to by all company employees.

4.1.2.3 Management Representative To effectively apply a quality system, the company should have a quality representative at a reasonably high management level. This person should be given enough authority to enforce the quality policy, to maintain and improve the efficiency of the quality system and to influence management decisions that improve the company's quality system. This person can also have other functions. The quality representative is known by everyone in the company. Your quality representative is active, visible and credible and has sufficient influence to ensure that the company constantly improves in order to meet customers' expectations.

Your quality representative ensures, on a scheduled basis, that your quality system is functioning efficiently and works with management to make improvements as required.

This person's authority and responsibilities are clearly defined and documented.

The documented account of this person's responsibilities and authority accurately reflect the company's actual situation.

4.1.3 Management Review Company management is responsible for establishing a quality policy and for instituting a quality system which respects the policy. Management is further responsible to ensure that the system continues to serve its purpose, that it remains appropriate; in short, that it works. Management should therefore ensure the system's efficiency, suitability and application through a management review. All documentation, minutes of meetings etc., should be retained in order to demonstrate that the system is producing the anticipated results. If the system is not responding to the company's expectations, management reviews should lead to corrective action. There are sufficient meetings among department heads to discuss quality concerns within the company.

These meetings are held on a regular basis and are always structured. During these meetings, all principle subjects or specific objectives concerning quality and the quality assurance system (audits, corrective and preventive actions) are discussed.

The meetings permit tracking and constant improvement of quality and give us a forum to make decisions that ensure the system remains effective.

Meeting results are sufficiently documented so as to allow us to make improvements.

Meeting notes are kept for a sufficient period of time to allow reference as required. Meeting notes show that recommendations have been applied and changes introduced.

4.2 Quality System A good quality system allows a company to run all functions effectively, from the taking of a customer's order to the receipt and use of the product or service by the same customer. The objective of the system is to consistently respond to quality expectations of all customers. The system not only influences product development and production, but also all other functions which influence the product or service (sales, design, purchasing...). The system should be documented and permit the company to plan, coordinate and control all activities which influence quality. Employees are aware of work procedures and instructions applicable to their functions, know when to use them and refer to them as required. Employees understand the documentation and use it to obtain expected results. The company possesses quality plans or any other documents which explain the methods and sequence of activities that should be followed in the production of a project, produ ct or service, in order to ensure that all be of the highest quality and meet customers' requirements.

When a customer requests a product or service that differs from that normally offered by the company, all those affected by the changes are briefed to ensure the



offered by the company, all those affected by the changes are briefed to ensure the differences are respected. This information is formalized and always documented.

The documentation is sufficiently clear to guide employees in their work methods. The company possesses written work procedures or instructions that are easily understood by all who use them.

The company has a quality manual in which the its quality policies and objectives are described as well as the general methods used to guarantee the quality of all products and services.

The company's quality manual describes in detail how documentation of the system is structured. This manual is updated on a regularly scheduled basis.

On the whole, the company's quality manual covers all applicable standards.

4.3 Contract Review A complete review and good understanding of the customer's expectations is essential in order to plan and deliver quality products and services. This review must be done prior to the submission of a bid and until the contract is accepted and the work begun. The purpose of such a review is to identify particular or irregular needs of a customer and to ascertain that the company possesses the means and ability to respond to all requirements specified in the contract. This contract might be a telephone order, a verbal or written agreement, or any other type of communication in which the company commits to responding to a customer's needs. There is always a review of the tender prior to submitting a bid, in order to ensure that the company is capable of meeting all requirements.

There is always a review of orders received in order to identify irregular requests

There is always a record kept of a customer's requirements, even if the order is placed verbally.

Even verbal orders are subject to a contract review. Documented procedures exist to ensure that we fully understand a customer's needs and that all ambiguities or differences have been clarified prior to acceptance. All modifications to an order or a contract are recorded. The company possesses documents which demonstrate that procedures for revising customers' orders, contracts and tenders are followed to the letter.

The company will not accept an order that it is not capable of filling satisfactorily. All contracts are reviewed and verified by an authorized person All contracts are recorded and kept for the entire contract period and for a long enough time to ensure all aspects of the customer's requirements, as well as all legal requirements, have been met.

The company's procedures clearly and precisely describe how all contract modifications are to be communicated to various functions within the organization as well as to subcontractors (suppliers), in order to ensure that these modifications are followed in both current and future contracts.

4.4 Design Control (ISO 9001 only) 4.4.2 Design and Development Planning The design of certain products or services sometimes stems from a company's responsibility. It is in response to specific needs that the company develops an idea. The company takes steps to meet these needs. Activities that lead to the development of a product or service must be well defined and planned. They should demonstrate that personnel are competent and have all necessary skills. All of these activities should be documented. The company always establishes an effective plan to follow when designing new products or services, in order to ensure that requirements as specified by the customer are met.



customer are met.

The company sets out well defined links between those implicated in the design.

The company always ensures that the design and development plan is updated as required. This plan clearly identifies the responsibilities, roles and tools which will apply to those involved in the design of products or services.

This plan includes validation and verification activities throughout the design phases These validation and verification activities are always followed by the company. These validation and verification activities are always documented. The company has clear and precise procedures that describe in detail how a design is planned and controlled.

4.4.4 Design Input

Prior to the company beginning to design a product or service, all necessary information, including legal and regulatory requirements, is identified and discussed with the various people who will be involved in the design process.

Documented procedures describe and properly direct the necessary identification, documentation and revision of design input requirements.

Documentation of design input requirements is on file and easily accessible. Records indicate that procedures to identify and revise design input requirements are followed precisely.

4.4.5 Design Output

The company always ensures that the design output for a product or service satisfies the customer's requirements.

Documentation pertaining to design output is up to date and easily accessible The company can demonstrate, using documentation, that a review of the design output was conducted prior to its release. Documented procedures clearly describe the requirements pertaining to design output.

During the design of a product or service, the company strives to identify all critical information which should be included in the design output, to ensure both proper completion and functioning of the product or service.

The company always defines the design acceptance criteria to which the product or service must conform.

4.4.6 Design Review

The company carries out design reviews in all planned phases of the project with those responsible for ensuring design feasibility.

The company has records of all reviews conducted. Documented procedures encompass formal design review planning. Records clearly demonstrate that design reviews are regularly evaluated for all appropriate design phases.

4.4.7 Design Verification

In design and development, verification pertains to the process of examining the result of an activity in order to determine to what extent it conforms with the activity's requirements. The company possesses documented procedures which clearly outline how design verification activities are planned and how they should be carried out and controlled.

The results of design verification activities are easily accessible. The results of design verification activities and other records clearly confirm that verification procedures are precisely followed.



4.4.8 Design Validation

In the design and development stage, validation concerns the process of examining a product in terms of its conformity to the user's needs. Validation is normally done of the final product, with well defined conditions of use. It could also be necessary during the earlier phases. The company always ensures that the product or service conforms to the user's needs.

The company possesses well documented procedures which show how it ensures that the product conforms to the user's needs.

The results of design validation are easily accessible

The results of design validation and other records clearly confirm that verification procedures are precisely followed.

4.4.9 Design modification

The company always ensures that only authorized persons with appropriate qualifications may change or modify the design of a product or service. These same people always conduct a review of the changes or modifications prior to approving them and beginning production.

Documented procedures encompass the identification, documentation, revision and approval of design changes.

Procedures for administering design changes are followed precisely and prevent problems which could arise as a result of these changes.

4.5 Document and Data Control Generally, when the company documents an internal function, it is done to reach specific objectives. These objectives include providing direction to employees and ensuring consistent quality of its products and services. Documentation is relevant when it impacts positively on a situation and when it is both useable and used. It is therefore important for the company to maintain updated, useful and timely information. Procedures used by company employees are regularly revised and updated whenever it becomes apparent that they no longer meet the needs of the users or the company.

Employees know that procedures and documents exist to which they can and sometimes must refer when it is necessary to clarify a situation which might affect quality.

Employees have constant access to documentation that is essential to the accomplishment of their tasks.

Whenever documents (plans, procedures, designs, etc.) become obsolete, they are immediately removed or identified to prevent any errors being made.

There exist no obsolete documents within the company that could be accidentally used and result in the customer's requirements not being respected

Documentation distribution is effective within the com pany, as documents are distributed to the appropriate users upon first being issued or any time they are updated.

Documentation is always reviewed and approved by those competent in the function prior to being published and distributed.

Those employees or functions responsible for examining modified documents prior to publication are the same as those who examined the original documents.

Documents which have been modified are always proof-read and re-approved prior to publication. Clearly defined methods for issuing, withdrawing and modifying all documents are part of a set of standard procedures.

Written procedures adequately describe how changes to documentation should be reviewed and approved.

There exists a master list of all documentation pertaining to the quality system which is easily accessible.

This master list, or its equivalent, records modifications made and indicates those revisions to documents currently in use.



4.6 Purchasing The company purchases products and services which enter into the production of its own products and services and have an impact on their quality. The company should identify the products and sub -contractors which have a significant impact on the quality of its own products and should introduce methods to evaluate them. 4.6.2 Evaluation of Subcontractors

The company has listed and clearly identified subcontractors of products that are crucial in the production of the company's own products and services.

Orders for these crucial products are always placed with approved subcontractors. Sufficiently documented procedures exist which outline the approval or rejection process for subcontractors of crucial products.

An up-to-date list of approved subcontractors is easily accessible. Should a supplier fail to meet our company's requirements, the company either stops buying from that supplier or tightens the controls on the products provided by that supplier.

The company always conducts an evaluation of its subcontractors (suppliers) prior to adding them to the list of approved suppliers.

The company does not select suppliers exclusively by their prices. The company keeps records of evaluations of all subcontractors who have an impact on the quality of its products.

4.6.3 Purchasing Data

Purchasing documents are always explicit enough that no error can be made in products ordered.

All information pertaining to the product approval and delivery are written on the order form (specifications, plans, control data, applicable standards, revision numbers etc.).

All purchasing documents are proof-read and approved prior to being issued.

Whenever our requirements for a given product change, our suppliers are advised rapidly.

Documented procedures clearly outline purchasing criteria and the approval process. These procedures are always followed by those responsible for issuing purchasing documents.

4.6.4 Verification of Purchased Product

Whenever you intend to inspect a product purchased from a subcontractor, you specify so on the purchasing document. Whenever one of your customers wishes to inspect a product purchased from your subcontractor, you specify this on the purchasing document sent to the subcontractor, so that he is aware of and accepts this possibility.

Even if your customer inspects and accepts a product purchased from you or your subcontractor, you ensure the product meets the customer's requirements.

4.7 Control of Customer-Supplied Product It sometimes occurs that customers supply us with products to incorporate into a product being produced for them. Customers might also supply documents, plans, molds or other items. In certain instances, products may be returned to us for modification or repair. Although these products belong to our customers, we must handle them as though they are our own. If this situation does not apply to your company, please skip this section. The company ensures that all items belonging to customers are well identified so as not to be confused with other items

The company pays close attention to the handling and use of products belonging to customers. It strives to ensure that none are damaged or lost.



customers. It strives to ensure that none are damaged or lost.

Should a product belonging to a customer be damaged or lost, the company informs the customer as quickly as possible.

Products supplied by customers are rarely lost, damaged or poorly handled. Documented procedures encompass the verification, storage, identification, registration and maintenance of products supplied by the customer.

4.8 Product Identification and Traceability To ensure the proper products are used in our work, it is essential that they be clearly and precisely identified to avoid any errors. This identification could consist of a name, a number, a stamp, a colour code or any other method that allows a product to be distinguished. Traceability is useful in that it permits the company to identify the source and root cause of a problem, trace the origins of the material and parts, track the history of an item's production process or the placement of a product after delivery. Traceability might also be a customer's or company requirement, and can be a helpful tool in problem identification and our improvement process. Products are identified in a s pecific way throughout the production process of your company.

Whenever traceability is required, the company maintains a numbered up-to-date list of its products and lots.

Very few problems have occurred as a result of identification errors or use of the wrong item.

Product identification is clear and precise for all products or services and people have a good understanding of the process The company can easily trace the origin of a problem or products that have been affected by an error caused by misuse of an item.

A product's quality plan, or similar document, describes procedures to identify and trace the product during production, delivery and installation stages

Product identification and traceability procedures work well when they are required during a product recall.

4.9 Process Control In a company where a quality system is in place, operations which might impact quality are identified, delineated and maintained. The company should post clear and precise instructions in those locations where an absence of directions might lead to lower quality or a lack of consistency in the quality necessary to meet customers' requirements. The company must pay particular attention to processes that cannot be controlled through monitoring or a subsequent product test. These processes, which require pre-qualification of their capability are frequently referred to as special processes (i.e. welding, painting, gluing). The company has identified all processes and methods which could affect the quality of its products or services.

The company has identified all parameters which are critical in monitoring and controlling its processes. These processes and methods are well documented with clear and precise procedures.

These procedures are followed throughout the company by those who are involved in the processes and methods.

These procedures are always accessible and are known and understood by all who use them.

Production equipment is properly maintained to ensure that the company is able to continually meet customers' requirements

Documented procedures clearly describe how to proceed with identification, planning, documentation, institution and control of the processes which directly affect quality.

Current process descriptions are easily accessible to users. Documented procedures exist which permit identification of special processes otherwise not verifiable by inspections and subsequent tests and which require particular attention in the area of procedure control.



Procedures which apply to special processes are always followed to the letter.

Records are kept of processes, equipment and qualified personnel as appropriate. These records are always up to date.

Prior to beginning production of a standard or special product, the company always ensures that the necessary production documentation is in place and provides a clear definition of production criteria that must be respected.

Prior to beginning production of a standard or special product, the company always ensures that processes and equipment are adequate.

The company monitors its processes and methods on a regularly scheduled basis.

This monitoring system is sufficiently documented to demonstrate that it is conducted regularly.

4.10 Inspection and Testing Quality standards demand that inspection levels be scheduled and conducted according to their respective plans. This includes inspections made when receiving goods, controls done during production and final inspection and testing. 4.10.2 Receiving Inspection and Testing

Personnel who receive merchandise are fully cognizant of the list of products they must inspect.

Personnel who receive merchandise are fully cognizant of how to inspect products they receive. During the receiving inspection of merchandise, personnel also verify accompanying documentation (i.e. analysis certificate).

When we receive merchandise, it is easy to know which products have been inspected and which have not.

Products which do not pass inspection are always identified and isolated to prevent them from entering into the production process. Control methods used when receiving products permit identification of those of poor quality.

Even if an employee is not sure whether a given product is subject to inspection, documentation exists which identifies those which must be inspected.

This documentation indicates what to inspect and how to carry out the inspection.

Should a product be urgently required prior to its having been accepted, the company ensures that the product can be traced during production in order to correct any potential problems.

The company clearly documents the methods by which to identify and register any product that is used prior to being accepted and outlines how this product should be returned in the event of problems.

Inspection procedures for purchased products are consistently followed and no problems have been linked to purchased goods or services.

The company has up to date, accessible records which attest to the quality of purchased products. 4.10.3 In-process Inspection and Testing

Points at which in-process inspections are necessary are known in all areas of the company.

Critical points where product quality could be lacking and affect quality downline are always covered by inspections or controls in your company.

Points during the production process where the company conducts inspections permit detection of problems at their source effectively

Products which do not pass in-process inspection are always identified or isolated to prevent them from entering into subsequent phases of production.

In-process inspection procedures are always followed. Very few problems detected in the final inspection could have occurred during the production process.



Clear and precisely documented procedures, covering in-process tests and inspections, are available to those who conduct the inspections.

This documentation explains to them what to inspect, how to inspect and when to inspect.

In-process inspection records are easily accessible. 4.10.4 Final Inspection and Testing

During the final inspection, authorized employees always verify whether all scheduled inspections for previous production stages have been accordingly conducted and whether the results of these inspections demonstrate that the product meets requirements.

Products that do not pass the final inspection are always identified and isolated to prevent their being used or delivered until such time as authorization is given for their use or delivery.

The results of quality inspections, customer complaint analyses and customer satisfaction surveys indicate that final inspections prevent problems from reaching the customer.

Clear and precisely documented procedures, encompassing final inspections and testing, are available to those employees who conduct the inspections.

This documentation explains to them what and how to inspect. Final inspection procedures are constantly followed by those responsible. Final inspection and testing records clearly show that the product or service does or does not pass established controls and tests .

The company always ensures that the control procedure for products that do not meet standards is applied when a product or service fails to pass controls and tests.

Final inspection and testing records always state the name or identification of the person who conducted the inspection or test.

4.11 Control of Inspection, Measuring and Test Equipment To measure the quality of its products or services, the company uses inspection, measuring and test equipment. Whether the equipment be mechanical, electronic or of any other type, it must be of the required precision and provide exact measurements. The company should therefore have equipment that impacts the quality of its products and services checked on a regularly scheduled basis, in order to ensure that it remains in good condition and retains the desired precision. Each piece of measurement equipm ent has its own identification, which permits the company to distinguish it from other, similar equipment. Ideally, this identification is a specific number inscribed on the equipment.

The company checks or has checked or calibrated on a scheduled bas is any equipment which impacts quality and this schedule is always respected.

Whenever equipment is checked, the company ensures the verification is conducted in a suitable environment which cannot interfere with or affect the results.

When the company checks its equipment, it does so following a documented procedure. For all equipment that bears identification, records are available which indicate acceptable precision limits, dates of calibration or checks and results obtained. Records include action taken when equipment was found to be outside acceptable limits and these records are always up to date.

Central records and equipment labels indicate that checks are conducted on a scheduled basis and that no equipment is in operation which does not meet standards.

Equipment labels and calibration records clearly show when the next check for that equipment is scheduled.

Personnel responsible for the control of measuring and test equipment always ensure that they are using the correct equipment for the task and that this equipment is in good working order.

Specific, documented procedures outline in detail the identi fication, control, calibration and maintenance of all inspection, measuring and test equipment.



These procedures permit the company to ensure that equipment is functional and clearly outline steps to take should equipment not meet acceptable standards.

Should measurement and test equipment fall outside of fixed limits, the company always investigates what impact this situation might have had on previous measurements and control results provided by the same equipment.

The company has a specific procedure that covers equipment which falls outside of fixed limits and this procedure is known by all personnel who use measurement and test equipment.

All those responsible for equipment which does not meet standards know of the procedure and immediately act in accordance with it.

All equipment used for measurement is protected from manipulation which could invalidate its calibration settings.

A procedure exists and is known and applied by all which ensures that the storage and handling of equipment do not affect instrument accuracy and precision

4.12 Inspection and Test Status During their progression, products and services are transformed, inspected, accepted or rejected on a regular basis. The status of a product should always be evident and available for those who may need to use it. The status should indicate product conform ance or nonconformance with regard to inspections and tests performed. If the product does not conform to standards, its status will prevent it from being used or accidentally sent to the customer. Procedures for inspection and test status work well. There are no known examples of products used prematurely or released erroneously. No time has been lost due to confusion about inspection and test status.

Employees are always able to learn the status of a product quickly and easily, i.e. whether it conforms to standards or not. Appropriately documented procedures assure identification of inspection and test status from the beginning of production through to installation.

Records identifying the authorities responsible for product release of a nonconforming product are easily accessible

A change in the status of a product is always made by those with the authority to do so.

It is always possible to know who has conducted inspections and testing of a product or service.

4.13 Control of Nonconforming Product Certain processes may occasionally produce products or services that do not conform to standards. The company must ensure that these products and services neither be used nor unintentionally delivered. A product found to be nonconforming is always isolated when necessary and possible or identified in such a way that it cannot be erroneously used.

Documented procedures exist in order to ensure that a nonconforming product not be erroneously used, delivered or installed.

These procedures are well applied throughout the company. The company has never been obliged to recall a product which was used or delivered when it did not conform.

4.13.2 Review and Disposition of Nonconforming Product

When a product or service is found to be nonconforming, it must be examined according to written procedures which outline which actions to take (repair, recall, acceptance with or without customer consent, reclassification or rejection) to meet specified requirements. The company has established formalized and documented procedures covering the control of nonconforming products, which guide employees in their work as well as in the analysis of nonconforming products

Whenever the company repairs or reworks a nonconforming product in order to bring it up to standard, this product is always re-inspected by authorized personnel Observations and discussions with employees indicate that formal procedures for the revision and handling of nonconforming products are followed to the letter and that they meet customer and company requirements.



that they meet customer and company requirements.

Records of all nonconforming products are available and kept up to date, indicating action taken with these products.

A report exists for all products found to be nonconforming and this report is communicated to all persons concerned with the nonconformities

All company employees know those who are authorized to conduct inspections and make decisions concerning nonconforming products.

Only those persons responsible and authorized to deal with nonconforming products do so.

4.14 Corrective and Preventive Action Despite the best intentions, unforeseen situations may arise which impede the company's efforts to assure quality. Quick, effective, corrective action can improve the performance of both the quality system and the organization. Corrective action should focus on eliminating the cause of problems. The company should also investigate changes that could be made to prevent a recurrence of the situation. 4.14.2 Corrective Action

When quality problems arise (i.e. customer complaints, rejections, identification errors, shipping errors, poor quality, procedural errors, recalls), those employees responsible to do so take immediate action to correct the situation.

Action taken by these people to correct such problems are always effective. The company conducts an on-going follow-up of the development of nonconformities and takes corrective action as required during the process. Whenever corrective action is necessary, those responsible document the action taken.

The company possesses records of these actions to demonstrate that they are effective and useful in the improvement of production operations as well as in the improvement of product quality.

The company possesses explicit and clear procedures to help and guide those responsible for taking corrective and preventive action

These procedures are followed to the letter throughout the company Upper management revises corrective actions regularly.

Preventive Action ( point 4.14.3 )

When problems arise (i.e. complaints, rejections, identification errors, shipping errors, poor quality, procedural errors, recalls), there are people responsible for identifying potential causes and ensuring that these problems not recur or that their incidence decreases.

Action taken by these people to prevent such problems are effective. The company possesses explicit procedures to help and guide those responsible in taking preventive action.

These procedures are followed to the letter. When preventive action is necessary, those responsible document the action taken. The company possesses sufficient records of these actions to demonstrate that they are effective and useful in the improvement of production operations as well as in the improvement of product quality.

Upper management revises preventive actions regularly.

4.15 Handling, Storage, Packaging, Preservation and Delivery



The handling, storage, preservation and delivery of the product directly and indirectly influence the quality of the product or service provided. Inadequate protection during handling can result in a deterioration of the product or in its contamination, squandering efforts that have brought it to that point. The company must establish and maintain up to date written procedures to ensure products are well protected during these activities and to ensure conformity to specified requirements. No problem has occurred through poor handling or a deterioration of products while in the care of your company.

Rarely is merchandise returned due to packaging which was insufficient to protect goods during shipping. The company receives no complaints on this subject.

Employees know very well how to handle all products (fragile, dangerous, etc.) in such a way that quality is not affected.

Documented procedures covering the handling, storage, packaging, preservation and delivery of products are present in the quality plan or available in separate documentation.

These procedures prevent problems, damage or deterioration Records demonstrate that all these procedures are effective and functioning well in the company.

4.16 Control of Quality Records Quality records demonstrate that conformity to specified requirements has been obtained and that the company's quality system works. These records include results, for example, of inspections, internal or supplier audits, corrective actions, of reports of nonconformity, or any other document which is part of the company's quality system. The quality recording system works well and facilitates inquiry whenever it is necessary to demonstrate product or service conformity to standards. We can easily demonstrate product conformity using these records.

The company possesses a list of records relative to audits, contract reviews, inspection and test results, corrective or preventive actions, required specifications, etc. These records can be made available at any time

Explicit, written procedures exist which explain how to identify, file, archive and store quality records in such a way that errors in the results are avoided and that conservation of and access to the records is assured.

When specified in a contract, the company always makes quality records available for evaluation.

The company always respects customers' requests as well as all applicable legal requirements in determining the length of time its quality records should be conserved.

The company explains thoroughly, in its procedures, how and when quality records may be disposed of.

The company always disposes of its quality records according to its procedures.

4.17 Internal Quality Audits Periodic, regular audits should be conducted according to an established plan. Audits serve to evaluate whether procedures are effective and being followed. Conducted by independent, qualified people, these verifications also give us an opportunity to evaluate the relevance of procedures in place and help to initiate actions to improve our quality assurance system and the way in which we proceed. The company conducts audits at defined intervals to verify the effectiveness of its various functions and of its quality system.

When it is necessary to take corrective action as the result of an audit, the company always does a follow-up to ensure that the action has been carried out correctly.

The audits have permitted the company to take action which has improved its overall efficiency. An adequate number of trained, independent people are available to carry out audit procedures.



Records of these audits indicate that recommended improvements are introduced quickly and efficiently.

Documented procedures adequately explain how to conduct, document and follow-up on internal audits of quality system procedures and results

These procedures are always closely followed by the personnel who conduct the audits.

4.18 Training The quality of our company's products and services is reflected in the skill of our personnel in the accomplishment of their work. It is very important that, in every position having an impact on quality, one finds employees possessing the required competence, training and experience. The company continually evaluates its training requirements for production employees who have an impact on the quality of its products and services The company continually evaluates its training requirements for employees who conduct inspections and tests.

The company continually evaluates its training requirements for customer service employees or those involved in installation.

The company possesses training files for its personnel and these files are continually updated. They demonstrate that personnel holding positions that impact on quality m eet the requirements of that position

These files clearly demonstrate that the requirements for every position that impacts on quality have been analyzed and outline specific criteria relative to initial and recurrent training, as well as to the experience required to fill the position.

When a employee is hired or assigned to a new position, the company ensures he or she has had the necessary training to do the job

Records show that the analysis of training needs is up to date and that the training and qualifications of all employees are adequate

Documented procedures are established to identify training needs of all personnel having an impact on quality.

4.19 Servicing One may find, within certain contracts, clauses which extend the relationship between a company and its customer beyond the delivery of a product or service. These are known as servicing clauses. They might involve maintenance or service guarantees for technical support, training of the customer's personnel, repairs or any other such requisite in the contract. Whenever these requirements are specified, the company must ensure they are respected. Servicing is part of what is generally known as contract-specified after-sale service. If you have no contracts which include servicing, please skip this question The company regularly conducts an analysis and associated follow-up to ensure that contract servicing clauses (after-sales service) are being respected

When the company conducts training as part of a servicing agreement, it evaluates the training to ensure it meets contract specifications

The company has written procedures to establish conformity with after-sale servicing requirements as specified in its contracts.

The company has procedures to verify and ascertain the extent to which its servicing meets specified requirements. When the after-sale service clause includes repairs, the company ensures that verbal or written agreement is obtained from the customer prior to beginning repairs.

All procedures relating to servicing are updated on an on-going basis in order to meet the needs of the company and its customers.

The company receives no complaints concerning contract-specified after-sale service.

4.20 Statistical Techniques It is important to forecast and evaluate whether processes and procedures used during production will meet the customer's needs or will permit these needs to be met. When appropriate, these evaluations can be made through statistical techniques. These techniques might consist of product sampling, control charts, statistical process control etc. The company should choose appropriate techniques and subsequently validate them to



process control etc. The company should choose appropriate techniques and subsequently validate them to ensure they are adequate. The company has identified areas where the use of statistical techniques is necessary to verify or control the effectiveness of its processes and the attributes of its products and services.

Employees who use statistical techniques in their work have a good understanding of their purpose and know how to use them.

The company uses statistical techniques regularly to verify or control the effectiveness of its processes and the attributes of its products and services and it has validated the techniques to ensure they are adequate

Written procedures exist where necessary to guide the application of statistical techniques.

The company has put a clear and precise procedure in place which allows identification of needs relative to the use of statistical techniques